Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (March 2013)
56 slides from Delcath Systems's investor presentation, Mar 4, 2013
Slide 1: Delcath Investor Presentation
Exhibit 99.1 Delcath Investor Presentation (NASDAQ: DCTH) March 2013
Slide 2: Forward-looking Statements
Forward-looking Statements Private Securities LitigationReform Act of 1995 provides a safe harbor for forward-lookingstatements made by the Company or on its behalf. This presentationcontains forward-lookingstatements, which are subject to certain risks and uncertainties that can cause actual result
Slide 3: Investment Considerations
Investment Considerations • Commercial stage company focused on oncology • Proprietary CHEMOSAT® Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer patients
Slide 4: Our Product
Our Product US Market Ex US Markets • Proposed Trade Name • Marketed under the trade name TM Melblez Kit (Melblez (melphalan) for CHEMOSAT ® Hepatic Delivery Injection for use with the Delcath System Hepatic Delivery System) • Proprietary Drug/Device Combination • Regulated as a Class IIb Medical Pr
Slide 5: The Delcath Hepatic Delivery System
The Delcath Hepatic Delivery System 1. ISOLATE 2. SATURATE 3. FILTRATE • Improves disease control in the liver • Treats macro and micro tumors • Controls systemic toxicities • Allows for over 100x dose escalation at tumor site Minimally Invasive, Repeatable Procedure That Could Complement Systemic T
Slide 6: Melanoma Liver Metastases
Melanoma Liver Metastases • A challenging histology • Notoriously insensitive to systemic chemotherapy and focal interventions • CHEMOSAT has demonstrated ability to extend progression free survival Our Opportunity • Ability to achieve ultra-high concentrations of chemotherapy provides potential tre
Slide 7: Clinically Differentiated Results
Clinically Differentiated Results • Phase 1, 2 and 3 trials with percutaneous hepatic perfusion (PHP) produced positive results in multiple histologies • Melanoma Liver Mets o Positive Phase 3 results in hepatic metastatic melanoma o n=93 (90% ocular melanoma, 10% cutaneous melanoma) • Neuroendocrin
Slide 8: Positive Phase 3 Results – Primary Endpoint hPFS
Positive Phase 3 Results – Primary Endpoint hPFS Hepatic progression-free survival (IRC) Proportion of patients surviving 1.0 5.3 mo Percutaneous Hepatic Perfusion (PHP) Best alternative care (BAC) 0.8 Hazard ratio = 0.50 0.6 (95% CI 0.31–0.80) P=0.0029 7.0 1.7 0.4 0.2 0.0 0 5 10 15 20 25 30 Intent-
Slide 9: Positive Phase 3 Results – Overall PFS
Positive Phase 3 Results – Overall PFS Overall progression-free survival (investigator) Proportion of patients surviving 1.0 3.8 mo Percutaneous Hepatic Perfusion (PHP) 0.8 Best alternative care (BAC) 0.6 Hazard ratio = 0.42 5.4 (95% CI 0.27–0.64) 1.6 P<0.0001 0.4 0.2 0.0 0 5 10 15 20 25 30 35 40 45
Slide 10: Overall Survival – Exploratory Subset Analysis
Overall Survival – Exploratory Subset Analysis TOTAL PHP vs BAC ONLY Proportion of subjects surviving 1.0 7.3 mo Total PHP incl. crossover 0.9 BAC only 0.8 0.7 0.6 0.5 4.1 11.4 0.4 0.3 0.2 0.1 0.0 0 12 24 36 48 60 Intent-to-treat population Months Overall Survival Tail For PHP Treated Patients 10 DE
Slide 11: Phase 2 Multi-Histology NCI Trial – Summary
Phase 2 Multi-Histology NCI Trial – Summary • Strong efficacy signals in mNET o 42% objective Response Rate (ORR) vs ~10% for approved targeted therapy o 66% patients had hepatic tumor shrinkage and durable disease stabilization • Positive Signal in primary hepatic malignancies (HCC and Cholangiocar
Slide 12: Phase 2 NCI Trial – Metastatic Neuroendocrine Cohort
Phase 2 NCI Trial – Metastatic Neuroendocrine Cohort Phase 2 mNET Tumor Cohort (n=24)* Number (n) Tumor Types Pancreatic NET 13 Pre-PHP (Baseline) Carcinoid tumor 3 Other NET 8 Response Partial Response (PR) 10 66% disease Stable disease (SD) 6 control Progressive disease 3 Post-PHP #1 Not assessed
Slide 13: Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort
Phase 2 NCI Trial – Hepatobiliary Carcinoma Cohort • Best hepatic tumor response by modified RECIST assessed by investigators o Partial response (PR) 1 patient o Stable disease (SD) 4 patients o Progressive disease 1 patient o Not assessed or evaluable 2 patients • Median duration of response o hPR
Slide 14: Phase 2 NCI Trial – mCRC Cohort
Phase 2 NCI Trial – mCRC Cohort • Substantial clinical evidence of benefit of using ultra-high dose melphalan to treat mCRC via isolated hepatic perfusion (IHP) procedure o Over 800 patients treated in 15 studies since 1998 o Patients treated only once o Median response rate of ~50-60% and median OS
Slide 15: Additional Clinical Data Generation
Additional Clinical Data Generation • Goals: Expand US (PHP: MEL) label indications beyond the initial indication we are seeking Generate robust clinical data to support commercialization • FDA has accepted IND Amendment to include Gen 2 device in Expanded Access Program (EAP), compassionate use (CU
Slide 16: 2013 Clinical Development Plan
2013 Clinical Development Plan • Planned company sponsored trials, subject to agreement with FDA Hepatocellular carcinoma (HCC) o Global Phase 3 Randomized CHEMOSAT Melphalan vs. best supportive care (BSC) for patients where Sorafenib is inappropriate - Primary endpoint: Overall Survival Advanced co
Slide 17: CHEMOSAT - Potential Multi-Billion Dollar Global Market
CHEMOSAT - Potential Multi-Billion Dollar Global Market 200,000 $2.3B Initial Opportunity HCC 189,943 • $100M Initial on-label CRC opportunity in Ocular 175,000 NET Melanoma in US* Melanoma 150,000 • $2.2B multi-histology opportunity in EU 99,749 125,000 100,000 75,000 55,389 52,143 50,000 42,367 7,
Slide 18: Global Commercialization Status
Global Commercialization Status Approved (CE Mark Device) NDA Filing Accepted by the FDA with PDUFA goal date of June 15, 2013 Mutual Recognition of European CE Mark – Applications Planned or Submitted Addressing A Multi-Billion Dollar Global Market 18 DELCATH SYSTEMS, INC
Slide 19: CHEMOSAT: EU Launch Underway
CHEMOSAT: EU Launch Underway • Marketing in target EU countries - Italy, Germany, France, UK, Ireland, NL, Spain • Training completed in key centers o Eight EU Clinical Sites activated in 2012 • EU clinicians using CHEMOSAT for a broad range of liver metastases o Use includes: cutaneous melanoma, oc
Slide 20: CHEMOSAT: Multiple Tumor Types Treated in Europe
CHEMOSAT: Multiple Tumor Types Treated in Europe • Physicians are recognizing the potential of CHEMOSAT in various tumor types • CHEMOSAT utilized in Germany, Italy, UK, France, Ireland • EU Registry To Be Initiated Q2 20 DELCATH SYSTEMS, INC
Slide 21: U.S. NDA Under Review
U.S. NDA Under Review • Oncology Drug Advisory Committee (ODAC) panel scheduled for May 2, 2013 • PDUFA date: June 15, 2013 • Initial indication: unresectable metastatic ocular melanoma in the liver o Provides lowest risk pathway to FDA approval and fastest access • NDA filing included: o Comprehens
Slide 22: U.S. Commercialization Strategy
U.S. Commercialization Strategy • Launch in Q4 2013 assuming approval on PDUFA date of June 15, 2013 • Initial commercial focus on centers that are active in the EAP or participated in the Phase 3 clinical trial • Utilize active EAP hospitals as Centers of Excellence for training and support of new
Slide 23: Barriers to Entry
Barriers to Entry • Patent Protection o 6 U.S. patents in force and 6 U.S. patent applications pending o 9 foreign patents in force (with patent validity in 25 countries) and 14 foreign patent applications pending o Primary US device patent set to expire August 2016 o Up to 5 years of patent extensi
Slide 24: Financial Summary
Financial Summary Cash & Cash Equivalents: $23.7 million at December 31, 2012 (unaudited) ATM Program $21.5 million remaining as of December 31, 2012 Committed Equity Financing Facility (CEFF) Up to $32.8 million as of December 31, 2012 Working Capital Line of Credit: $20 million credit facility Deb
Slide 25: Management: A Track Record of Success
Management: A Track Record of Success Years of Executive Title Prior Affiliation(s) Experience Eamonn Hobbs President and CEO AngioDynamics, E-Z-EM 32 D&B, Pagoda Pharma, Schering-Plough, Graham Miao, Ph.D. EVP & CFO 23 Pharmacia, JP Morgan Krishna Kandarpa, M.D., CSO and EVP, R&D Harvard, MIT(HST),
Slide 26: 2012 Accomplishments
2012 Accomplishments • First patients treated with CHEMOSAT Melphalan in Europe in January • Obtained CE Mark for Gen 2 CHEMOSAT Melphalan filter in April • Executed contract for MSL services in EU in 1Q 2012 (Quintiles was selected to support EU launch of CHEMOSAT) • Secured agreements with 14 lead
Slide 27: 2013 Anticipated Milestones
2013 Anticipated Milestones First patient enrolled in EAP - Q1 2013 Obtained NUB Value 4 interim reimbursement in Germany – Q12013 • Obtain interim reimbursement in UK – Q2 2013 • Submission for publications of Phase 3 data and mNET arm of Phase 2 data in Q1 2013 • Initiate EU Registry - Q1 2013 • O
Slide 28: A Compelling Investment Opportunity
A Compelling Investment Opportunity • Commercial stage company focused on oncology • Proprietary CHEMOSAT Hepatic Delivery System allows unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival • Addressing large unmet market need for cancer
Slide 29: DELCATH SYSTEMS, DELCATH
© 292011 DELCATH DELCATH SYSTEMS, SYSTEMS, INC INC. ALL RIGHTS RESERVED
Slide 30: Appendices
Appendices 30 DELCATH SYSTEMS, INC
Slide 31: Liver Cancer Treatment Options
Appendix 1 LIVER CANCER TREATMENT OPTIONS 31 DELCATH SYSTEMS, INC
Slide 32: The Problem
The Problem • Metastatic disease to the liver, brain or lungs is often the life- limiting location of solid tumors o Often life-limiting or leads to withdrawal of systemic treatments in favor of palliative care • Effective treatment for patients with liver-limited or dominant cancers remains a clini
Slide 33: Existing Liver Cancer Treatments Have Limitations
Existing Liver Cancer Treatments Have Limitations Treatment Advantages Disadvantages – Non-invasive – Systemic toxicities Systemic – Repeatable – Limited efficacy in liver – Invasive/limited repeatability Regional – Therapeutic effect – Multiple treatments are (e.g., Isolated Hepatic Perfusion) – Ta
Slide 34: Diffuse Hepatic Metastases from Melanoma
Diffuse Hepatic Metastases from Melanoma • Diffuse disease in the liver is prevalent • Effective treatment for patients with liver-limited or dominant cancers remains a clinical challenge • Whole organ therapy creates a new option for patients in the management of liver dominant disease 34 DELCATH S
Slide 35: Our Solution – Whole Organ-Focus Disease Control
Our Solution – Whole Organ-Focus Disease Control • Our proprietary CHEMOSAT System isolates the liver circulation, delivers an ultra-high concentration of chemotherapy (melphalan) to the liver and filters most of the chemotherapy out of the blood prior to returning it to the patient • The procedure
Slide 36: Market Opportunity by Disease & Target Countries
Appendix 2 MARKET OPPORTUNITY BY DISEASE & TARGET COUNTRIES 36 DELCATH SYSTEMS, INC
Slide 37: Market Opportunity by Disease (patients)
Market Opportunity by Disease (patients) • Europe – Largest near-term opportunity • CRC – Largest opportunity worldwide • Melanoma – Largest opportunity is in the US • China – Largest opportunity for HCC Market Opportunity defined as Total Potential Market (TPM) for Melblez Kit/CHEMOSAT 1.Primary ca
Slide 38: Europe Market by Disease – Device Only
Europe Market by Disease – Device Only Total Potential Germany UK France Italy Spain Netherlands Ireland Potential Market (Direct) (Direct) (Indirect) (Indirect) (Indirect) (Direct) (Direct) 1,2,3 (patients) ($ MM) Total Potential Market #Patients Ocular Melanoma 404 297 295 285 197 79 19 1,576 $ 62
Slide 39: US Market by Disease – Device and Drug Combination
US Market by Disease – Device and Drug Combination Potential Market Potential Market Potential Market Liver Metastasis 1,2 # Patients # Procedures ($MM) Ocular 1,685 4,213 $ 105 Melanoma Cutaneous 7,023 17,557 $ 439 Melanoma CRC 19,861 49,653 $ 1,241 HCC (Primary) 5,586 13,964 $ 349 NET 8,212 20,530
Slide 40: APAC Market by Disease
APAC Market by Disease Total Potential China S. Korea Japan Taiwan Australia Potential Market (Device) (Device) (Device) (Device) (Device) 1,2 (patients) ($MM) Total Potential Market #Patients HCC 85,780 3,258 8,296 2,152 263 99,749 $ 1,156 (Primary) Other CRC 31,127 3,245 14,298 1,441 2,031 52,143
Slide 41: High-Dose Melphalan History and Rationale
Appendix 3 HIGH-DOSE MELPHALAN HISTORY AND RATIONALE 41 DELCATH SYSTEMS, INC
Slide 42: The Evidence for Melphalan
The Evidence for Melphalan Melphalan, an established chemotherapy agent, is proven active at high doses with broad antitumor activity 42 DELCATH SYSTEMS, INC
Slide 43: Melphalan Dosing & Background
Melphalan Dosing & Background Type Dosing (mg/kg) Multiple Myeloma (label) 0.25 Chemoembolization 0.62 Surgical Isolated Hepatic Perfusion (IHP) 1.50 Myeloablation 2.50-3.50 Percutaneous Hepatic Perfusion (PHP) 3.00 • Well understood, dose dependent, tumor preferential, alkylating cytotoxic agent th
Slide 44: Melphalan Sensitivity: In Vitro Tumor Cell Lines Study
Melphalan Sensitivity: In Vitro Tumor Cell Lines Study Apoptosis Induction Cone. (uM) for Apoptosis Induction Melphalan Sensitivity- Apoptosis Induction 192uM 200 2 3 100 50 — ¢ & ¢ ¢ ‘f & of e e of & "Ce SPSS vf é é e e Tissue of Origin of Cancer Cell Lines Melphalan Conc. Achieved We Believe Our T
Slide 45: Phase 3 Trial
Appendix 4 PHASE 3 TRIAL 45 DELCATH SYSTEMS, INC
Slide 46: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to PHP 93 patients: ocular PHP = Meblez Kit/CHEMOSAT or cutaneous melanoma PHP/Melphalan Best Alternative Care (BAC) Treat every 4 weeks x 4 rounds Cross-over Investigator and patient decision (responders can receive up to 6 rounds) (any and all treatments)
Slide 47: Positive Phase 3 Results
Positive Phase 3 Results • Primary endpoint (hPFS by IRC) exceeded, p value = 0.0029, hazard ratio of 0.50 as of June, 2012 o PHP median hepatic progression free survival (hPFS) was 4-fold of control, or 5.3 months improvement o PHP achieved a median hPFS of 7.0 months vs 1.7 months for BAC control
Slide 48: Published Phase 1/2 Studies of Doxorubicin with PHP
Appendix 5 PUBLISHED PHASE 1 / 2 STUDIES OF DOXORUBICIN WITH PHP 48 DELCATH SYSTEMS, INC
Slide 49: Phase 1 & 2 Studies of PHP-Doxorubicin For HCC
Phase 1 & 2 Studies of PHP-Doxorubicin For HCC 1) Ku Y et al. Chir Gastroenterol 2003;19:370–376. 2) Curley SA et al. Ann Surg Oncol 1994;1:389–99. 3) Ravikumar TS et al. J Clin Oncol 1994;12:2723–36. 4) Hwu WJ et al. Oncol Res 1999;11:529–37. Delivered Safely in Multiple Studies with Promising Resp
Slide 50: Product Development Pipeline
Appendix 6 PRODUCT DEVELOPMENT PIPELINE 50 DELCATH SYSTEMS, INC
Slide 51: Product Development Pipeline
Product Development Pipeline Initial Opportunity Near Term (< 5 years) Intermediate Term (> 5 years) • All liver cancers – melphalan • Classified as Medical Device rd • CHEMOSAT for additional drugs • 3 party melphalan • mCRC and HCC clinical trials • CHEMOSAT for other organs (lung • Gen 2 melphala
Slide 52: CHEMOSAT Delivery System for Doxorubicin – CE Mark
CHEMOSAT Delivery System for Doxorubicin – CE Mark • Satisfied all of the requirements to affix the CE Mark to Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin in October, 2012 o Provides a pathway for regulatory approval in Chi
Slide 53: Non US/EU Regulatory Update
Appendix 7 NON US/EU REGULATORY UPDATE 53 DELCATH SYSTEMS, INC
Slide 54: International Strategy beyond EU and US
International Strategy beyond EU and US • Leverage CE Mark to obtain reciprocal regulatory approvals for CHEMOSAT Systems in other international markets o Obtained approval for Gen 2 CHEMOSAT Delivery System for Melphalan in Australia • International regulatory submissions status: Application submit
Slide 55: CHEMOSAT Centers
Appendix 8 CHEMOSAT CENTERS 55 DELCATH SYSTEMS, INC
Slide 56: CHEMOSAT Centers in Europe
CHEMOSAT Centers in Europe • Entered training and marketing agreements with leading cancer centers in Europe o Milan, Italy – European Institute of Oncology (IEO) o Frankfurt, Germany – Johann Wolfgang Goethe-Universität (JWG) o Kiel, Germany – Universitätsklinikum Schleswig-Holstein o Villejuif, Fr